Envarsus XR Approved to Prevent Rejection in Kidney Transplant Patients
July 10, 2015 – The U.S. Food and Drug Administration approved Envarsus XR (tacrolimus extended-release), manufactured by Veloxis Pharmaceuticals. Envarsus XR is a calcineurin-inhibitor immunosuppressant indicated in combination with other immunosuppressants for the prophylaxis of organ rejection in kidney transplant patients transitioning from an immediate-release formulation of tacrolimus. Envarsus XR will not be launched until around the fourth quarter of 2015. Envarsus XR will be available as 0.75mg, 1mg and 4 mg extended- release tablets and is recommended to be taken once daily on an empty stomach.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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